Sanofi and Reneneron may continue marketing Praluent (alirocumab) in the US pending court appeal.
Regeneron Pharmaceuticals, Inc and Sanofi announced that the United States Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent (alirocumab) Injection pending the companies' appeal. This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process. Sanofi and Regeneron remain committed to ensuring patients who can benefit from Praluent continue to have access to this innovative therapy.
The companies are challenging both the injunction ruling and validity judgment during the appeal process. The companies believe Amgen's asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid in the ongoing U.S. patent infringement lawsuit.